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  • Preclinical & Laboratory Foundations Learning Path
  • Phase I – First-in-Human Trials Learning Path
  • Phase II & III – Efficacy & Pivotal Trials Learning Path
  • Clinical Trials Foundation PathNew
  • Regulatory Submission & Approval

About

Human error is often the visible outcome of deeper system weaknesses rather than the sole cause of quality events. Modern GxP organisations apply human performance principles to understand why errors occur, identify organisational and environmental contributors, and implement sustainable improvements that strengthen quality, patient safety, and operational reliability. A systems-based approach promotes learning, continual improvement, and a stronger quality culture.
This Human Error Investigation and Human Performance in GxP Training Course & Certification provides comprehensive knowledge of human performance principles, human error science, error-producing conditions, human factors, investigation methodologies, causal analysis models, learning-focused investigations, corrective action design, organisational culture, leadership responsibilities, quality risk management, and regulatory expectations for human-involved events. Upon successful completion, learners receive a certification demonstrating their understanding of human performance, effective investigations, and best practices for improving quality and reducing recurring errors in GxP-regulated environments.

Who Should Enrol?

  • Quality Assurance and Quality Management Professionals
  • Manufacturing, Production, and Operations Personnel
  • Quality Control and Laboratory Professionals
  • Deviation, CAPA, and Investigation Teams
  • Regulatory Affairs and GxP Compliance Professionals
  • Internal Auditors and Continuous Improvement Specialists
  • Managers, Supervisors, and Team Leaders in GxP-regulated organisations
  • Anyone involved in investigating quality events, improving human performance, or strengthening quality culture
📢 Every purchase also includes our FREE companion Human Error Investigation and Human Performance in GxP eBook, designed to help you apply principles in real-world clinical trial settings.

What you will learn

Understand the principles of human performance, the science behind human error, and how system factors influence performance within GxP-regulated environments.

Learn how to distinguish human error from system failures, identify error-producing conditions, and conduct objective, evidence-based investigations of human-involved events.

Develop knowledge of human factors analysis tools, causal models, learning-focused investigations, behavioural influences, and risk-based strategies for reducing repeat errors.

Gain practical understanding of human performance improvement, effective corrective actions, learning culture, leadership responsibilities, and integration of human performance principles into GxP quality systems.

Course Syllabus

  1. Human performance is a system property
  2. Slip, lapse, mistake, violation
  3. Skill-, rule- and knowledge-based performance
  4. At-risk behaviour
  5. Intentional violation and misconduct
  6. Error-likely situations
  7. Performance variability
  8. Just culture and accountability
  9. Quality culture and reporting
  10. Human performance and product/data quality

  1. Procedure complexity, ambiguity and design
  2. Workload, staffing and time pressure
  3. Fatigue, shift work and interruptions
  4. Ergonomics and interface design
  5. Labelling and visual discrimination
  6. Training, competence and supervision
  7. Communication and handovers
  8. Maintenance, housekeeping and equipment state
  9. Incentives and production pressure
  10. The work-system scan

  1. Event reconstruction and context
  2. Preparing for a fair interview
  3. Open and non-leading questions
  4. Work-as-imagined vs work-as-done
  5. Procedure, training and task-observation evidence
  6. Organisational decisions and latent conditions
  7. Multiple causal pathways
  8. Bias and hindsight — guarding against them
  9. Distinguishing action from cause

  1. Five Whys — use and limits
  2. Fishbone with human and organisational categories
  3. Barrier analysis
  4. Change and task analysis
  5. Bow-tie and Swiss-cheese thinking
  6. Performance influencing factors and checklists
  7. Causal-factor charting
  8. Root-cause statement tests

  1. The hierarchy of controls
  2. Elimination, simplification and automation
  3. Forcing functions and poka-yoke
  4. Standardisation, visual management, checklists
  5. Independent checks — use with care
  6. Procedure, interface and label redesign
  7. Training used well — not as default
  8. Staffing, management controls and monitoring

  1. Just culture and psychological safety
  2. Near-miss reporting
  3. Learning teams and recurring-event review
  4. Human-error metrics — without perverse incentives
  5. Management review and OpEx integration
  6. Inspection expectations

  1. 📘 Bonus: Human Error Investigation and Human Performance in GxP eBook (Free with purchase)

Course Benefits

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Free eBook

Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever

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CPD Points

Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

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Certification

Receive a personal certificate to show your subject knowledge on course completion.

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Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

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Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

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Keep Up to Date

You will stay aligned with current effective texts including ICH Q9(R1) and ICH Q10, EudraLex Volume 4 Chapter 1, FDA 21 CFR 211.192 and pharmaceutical quality-system materials, and MHRA GMDP inspectorate guidance on investigations and human error and MHRA data-integrity and quality-culture principles. Transferable human-factors principles from safety-critical sectors are clearly identified as good practice, and draft or consultation material is flagged.

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Learn from Industry Experts

Content reflects the combined practice of human-factors and human-performance specialists, pharmaceutical quality investigators, CAPA specialists and process-improvement practitioners, expressed through worked examples and an integrated case study.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

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